Safe use of medicines during pregnancy
As a part of the WHO campaign “Safe maternal and newborn care” for World Patient Safety Day 2021, Friday 17 September, we at Sobi recognise the importance of reporting pregnancy and pregnancy outcomes during treatment with our medicines. By closely monitoring pregnancies we can provide better advice for healthcare professionals and our patients regarding their treatment.
“Despite the significant progress made in reducing maternal and neonatal mortality, a number of preventable pregnancy outcomes still occur, and a few of these are related to exposure to medicine use during pregnancy,” says Sobi’s Christina Ström Möller, Head of Global Pharmacovigilance & Patient Safety.
For a medicinal product to be approved for use, it needs to undergo a well-controlled clinical study programme establishing the safety and efficacy profile. When it comes to pregnant women however, the situation is different, and they are rarely included in clinical studies. This means that the assessment of potential risks associated with the use of the medicinal products in pregnancy usually relies on non-clinical data and the knowledge of adverse embryo/foetal reactions to other medicines with similar pharmacological properties. However the use of medicines during pregnancy is not uncommon; some treatments must proceed during pregnancy and many pregnancies are unplanned. This means that spontaneous reporting of pregnancies, after a product has been approved for use, is the main source of information of adverse reactions following drug exposure in utero or during breastfeeding. Many medicines therefore carry special warnings and are not used during pregnancy.
“By continuously collecting safety data and following pregnancies that we become aware of in a real-world setting, we aim to provide better information on safety in pregnancies to healthcare providers and patients, helping them to make informed decisions about health and treatment,” says Christina
At Sobi, we support the World Health Organisation’s objectives for World Patient Safety Day 2021:
- Raise global awareness on the issues of maternal and newborn safety, particularly during childbirth.
- Engage multiple stakeholders and adopt effective and innovative strategies to improve maternal and newborn safety.
- Call for urgent and sustainable actions by all stakeholders to scale up efforts, reach the unreached and ensure safe maternal and newborn care, particularly during childbirth.
- Advocate the adoption of best practices at the point of care to prevent avoidable risks and harm to all women and newborns during childbirth.
You can find out more about World Patient Safety Day at https://www.who.int/news-room/events/detail/2021/09/17/default-calendar/world-patient-safety-day-2021
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